benefits of the tag active control system for achieving … · ref: böckler et al., cx 2015 book...
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Dittmar BöcklerDepartment of Vascular and Endovascular Surgery
University Hospital HeidelbergUniversity Hospital Heidelberg | March 2018 | Prof. Dr. Dittmar Böckler
Benefits of the
Gore ® TAG® ACTIVE CONTROL System
for achieving optimal outcomes
in complex TEVAR
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Disclosures
University Hospital Heidelberg | March 2018 | Prof. Dr. Dittmar Böckler
• Consultant
– Cook, Endologix, Gore, Medtronic
• Research Grant
– Gore, Maquet, Medtronic, Siemens
• Advisory Board
– Endologix, Gore, Maquet, Medtronic, Siemens
• Paid Speaker
– Endologix, Gore, Maquet, Medtronic, Siemens
• Major Stokeholder
– none
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TEVAR is challenging – especially In the arch
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Ref: Böckler et al., CX 2015 Book Chapter, Biba Medical
Influencing Factors of Outcome after TEVAR
Patient related
Factors
Device related
Factors
Procedure &
operator
related factors
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Current Limitations Performing TEVAR
Profile (up to 24Fr.)
Inner wall apposition in the arch (Zone 0 &1)
Control during deployment (hemodynamic forces)
Preservation of aortic branches
Longterm durability (migration)
Clinical AE e.g. stroke, EL, Paraplegia
etc.
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19 Years of Stent Graft Evolution
TAG
1998
Conformable TAG
2009
CTAG with active control
2017
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Current CTAG Deployment Sequence
One step deployment
Mid to both ends
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Refinements for Device Accuracy
Maintain conformability of Conformable GORE® TAG®
Precurved olive for self orientation
New delivery system to 1. enhanced control
2. vessel wall apposition
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• Intuitive deployment system allow phsyicians to focus on the
patient , not the deployment system
• Optional steps can be skipped
• Lockwire keeps stent graft attached to catheter throughout
the procedure, enhancing control of the stent graft
CTAG with ACTIVE CONTROL System
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CTAG with ACTIVE CONTROL System
Staged deployment enables adjustment of placement and angulation
Continuous blood flow ensures hemodynamic stability
Opportunities to visualize & refine device placement
C-arm parallax correction
Device placement
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3 Important Steps for Deployment –not changed
1. (double) curved wireIn the ascending
2. Push stiff wire = deviceto the outer curve
3. Eliminate
stored energy
by pulling the device
back into intented
landing zone
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CTAG Experience Heidelberg March 1997 - January 2019
589 TEVAR Procedures
399 Patientswith CTAG
66 patients
with n= 93
CTAG with Active Control
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Benefits of the Device
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# 1 Conformable TAG is FDA Approvedto treat various thoracic aortic pathologies
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# 2 Oversizing window 6-33%adapting radial force to the underlying pathology
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# 3 High CoformbailityIdeal for aortic arch pathologies
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# 4 no bare stentsimportant for patients with fragile wall conditions
e.g. trauma, dissections and IMH
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# 5 short precurved oliveIdeal for Zone 0 , ascending and self-orientation
Arch Involvement 72% for all TEVAR (n=589)
Arch Involvement 68.2% for CTAG active control
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# 6 unsheathed deviceideal if multiple devices are needed (every 3rd pat)
and if percutaneous access
Every 3rd patient needs
more than 1 device
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# 7 staged deploymentparalaxis correction at intermediate deployment > accuracy
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# 7 staged deploymentNo rapid pacing > less invasive
more local anesthesia > time saving
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# 8 Optional angulationTo actively accomodate to individual arch morphology
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Use of Active Control (n=51)
Indications When / Where % (n)
Optional angulation used 26 % (13)
intermediate deployment alone 77 % (10)
intermediate and full deployment 33 % (4)
after full deployment alone 0
Depending on Arch Type Type I 15 % (2)
Type II 54 % (7)
Type III 31 % (4)
Underlying Pathology Degenerative disease (TAA & PAU) 54 % (7)
Disssection (AoD & IMH) 38 % (5)
Others 8 % (1)
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# 9 Stentgraft is fixedto the delivery system with lockwiresControl during deployment > precise placement
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„Pull and Pray“ = times over for this rumor
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# 10 New deployment sequencePrecise deployment at distal landing zones
close to celiac trunk
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# 11 Time for optimizationIdeal for teaching
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# 12 NEW: lowered profile (minus 2 French)To reduce/avoid access problems, percutaneous approach
First low profile CTAG active Control Implants 21st January 2019
Percutaneous in local anesthesia
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Strategy Change with CTAG Active Control
Liberal overstentig of supraaortic branches with
bares stents
Not with active control
due to second sleeve
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Technical Results (n=51)
% (n)
Technical Success 96 % (49)
Accuracy* Landing Zone 96 % (49)
Conformability * Bird beaking 96 % (49)
* Different patients Y> 4 in total
Defintions:
Technical Results : according to the reporting standards 1
Accurate placement was deployment within the intended LZ 2
Non-conformability: gap of more than 2 mm between the proximal
gold band and the inner aortic wall 2
1 Fillinger MF, et al. Society for vascular surgery Ad Hoc committee on TEVAR reporting standards reporting standards for thoracicendovascular aortic repair (TEVAR). J Vasc Surg 2010;52(4):1022-33.
2 Böckler D et al. Thoracic Endovascular Aortic Repair of Aortic Arch Pathologies with the Conformable Thoracic Aortic Graft: Early and 2 year Results from a European Multicentre Registry, Eur J Vasc Endovasc Surg (2016) 51, 791- 800
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Clinical Results (n=51)
SAE Specification % (N)
Endoleak Overall 17% (8)
Type Ia 0
Type Ib 4% (2)
Type II 12% (6)
Type III 0
Stroke Overall 4% (2)
Ischemia 1
Bleeding 1
Spinal Cord Ischemia Grading 3 b 1 4% (2)
1 Fillinger MF, et al. Society for vascular surgery Ad Hoc committee on TEVAR reporting standards reporting standards for thoracicendovascular aortic repair (TEVAR). J Vasc Surg 2010;52(4):1022-33.
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Summary
New CTAG has additional features:
Staged deployment
New deployment sequence
Optional angulation
Early experience is very convincing
New CTAG is about to overcome existing limitations
“Surpass Registry” started to gain more data
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Dittmar BöcklerDepartment of Vascular and Endovascular Surgery
University Hospital HeidelbergUniversity Hospital Heidelberg | March 2018 | Prof. Dr. Dittmar Böckler
Benefits of the
Gore ® TAG® ACTIVE CONTROL System
for achieving optimal outcomes
in complex TEVAR